Cryotherapy, the application of ice or other cold materials, is a proven modality for use in the initial treatment and the rehabilitation for a variety of musculo-skeletal injuries, including sprains, strains, contusions, and fractures. It has also been found to be useful in the rehabilitation process after minor surgery, such as arthroscopic surgery.
Generally, the goals of cryotherapy are to limit the formation of edema, to reduce pain, and to reduce muscle spasms. There are various types of devices, systems, and methods used today to apply cryotherapy including ice massage, ice immersion, cold whirlpools, ice bags, cold towels, cold gel packs, cold chemical packs, and vapor-coolant sprays.
It is known that clinical response to cryotherapy is improved if the cooling vehicle, such as an ice bag or gel pack, is cooled to a suitable low temperature and applied proximally to the joint or body part. The clinical response to cryotherapy is also improved if the cooling vehicle is kept sufficiently cold and applied continuously to the area during treatment. Generally, clinical response improves the longer the cooling vehicles are applied to the area. Unfortunately, most cooling vehicles generally lose their coldness in a relatively short time and must be replaced for extended treatment. Also, the application of the cold cooling vehicles for relatively long periods to the area can cause frostbite in the adjacent skin and superficial tissues. Moreover, the initial application the cooling vehicles to the skin surface often elicits a pain response which, after continuous application, gives way to an aching or throbbing sensation and then eventually to numbness.
The device and system used in the application of cryotherapy can also affect the clinical response. It is known, for example that for optimal treatment, the cooling vehicles should be positioned on opposite sides of the joint or body part so that deep, even penetration of cold treatment may be given. Many joints, however, such as the knee, elbow, ankle, and jaw, have sharp angles or protuberances which make proper alignment and placement of the device and the cooling vehicles difficult or impossible. Also, since extended cryotherapy treatment requires the continuous application of sufficiently cold cooling vehicles, several sets of sufficiently cold cooling vehicles must be on hand for exchanged in the device during treatment. Ideally, for optimal cryotherapy treatment, the cooling vehicles should be exchanged without removing the device from the joint or body part.
Heretofore, several devices have been used to apply cryotherapy to various joints and body parts using various cooling vehicles, such as ice bags or gel packs. Many of these devices, such as those disclosed in U.S. Patent Nos. 4,753,240, and 4,676,247, fail to address the problems listed above.
The present inventors have, therefore, determined that a new device, system and improved methods are needed for applying cryotherapy.
It is a general object of this invention to provide an orthopedic device that uses standard size cooling vehicles to apply cryotherapy to various joints or body parts.
It is an object of this invention to provide such a device that can be easily aligned and attached to the various joints or body parts including those having sharp angles or protuberances.
It is an object of this invention to provide such a device that disposes the cooling vehicles on substantially opposite sides of the joint or body part so that optimal therapeutic treatment may be given.
It is another object of the invention to provide a system for applying relatively long periods of cryotherapy to a joint or body part that uses the herein disclosed device.
It is further object of this invention to provide a method of applying cryotherapy which elicits little or no pain from the user when used initially.
It a still further object of this invention to provide a safe, optimal method of applying extended cryotherapy treatment.
These and other objects of the invention which will become apparent are accomplished by the device, system, and methods further described herein.
The device comprises an adjustable wrap structure made of flexible material that is capable of wrapping at least partially around various joints and body parts. In one embodiment, the wrap structure has a central region with two pockets manufactured on opposite sides thereof. Each pocket is formed by registering and attaching a flexible, thermal-conductive cover to the inside surface of the wrap structure. An extending edge of the cover is unattached to the inside surface thereby creating an easily accessible opening into each pocket.
During use, a sufficiently cooled or frozen cooling vehicle, such as an ice bag or gel pack, is placed inside each pocket and used to apply cryotherapy to the joint or body part. The position of the openings to the pockets on the inside surface of the device allows for the easy exchange of the cooling vehicle from each pocket without removing the device from the joint or body part.
A joint alignment means is located on the wrap structure's central region between the two pockets. The joint alignment means allows the device to be properly positioned and aligned on various joints or body parts. It is especially useful on angled joints or body parts or those having protuberances which make positioning and alignment of typical devices difficult. The joint alignment means comprises an opening or passage which enables the wrap structure to be aligned on the joint or body part so that the pockets are disposed on substantially opposite sides of the joint or body part for optimal cooling. Although the joint alignment means may be manufactured in any shape, in one embodiment disclosed herein, it comprises a circular passage through which the vertex or protuberances of the joint or body part may be partially extended.
A device attachment means is attached to the wrap structure for adjustably securing the device to the joint or body part. The device attachment means comprises at least one elastic strap permanently attached at one end to an edge of the wrap structure or pocket. During use, the opposite, detachable end of the strap is placed around the joint or body part and adjustably connected to the outside surface of the wrap structure located on the opposite side of the device. In one embodiment, the strap is made of elastic material which enables the device to be pulled slightly from joint or body part surface so that the cooling vehicles may be more easily removed and exchanged.
A strap attachment means is used to adjustably connect the detachable end of each strap to the wrap structure's opposite outside surface. In one embodiment, the strap attachment means comprises a pad-shaped hook connector and a pad-shaped loop connector disposed between the detachable end of the strap and the wrap structure's outside surface.
A system and improved methods for applying cryotherapy using the above described device is also disclosed herein. It has been discovered that the temperature of a joint or body part may be adjusted by exchanging different sets of gel packs, each having different freezing and cooling properties, in the device during treatment. The freezing and cooling property of the gel packs may be changed by altering the chemical composition of the coolant substance contained in each gel pack.
The system uses two or more sets of standard size gel packs placed inside each pocket during use. The gel packs containing a coolant substance comprised by volume;0.5% to 2% polymer gel, 3 to 10% glycerin, and 88 to 96.5% water. The compositions of each coolant substance is adjusted within the above ranges so that each set of two gel packs freezes at a different temperature below 32 degrees F. The first set of gel packs contains a coolant substance comprising by volume 1% polymer gel, 3% glycerin, and 96% water and freezes at approximately 28 degrees F. The second set of gel packs contains a coolant substance comprising by volume 1% polymer gel, 7% glycerin, and 92% water and, freezes at approximately 21 degrees F. An optional third set of gel packs contains a coolant substance comprising by volume 1% polymer gel, 10% glycerin, and 89% water, and freezes at approximately 10 degrees F.
Prior to use, all of the gel packs are stored at a temperature below the freezing temperature of the lowest freezing gel pack. It is known that the lowest possible temperature of a gel pack is limited by the freezing temperature of the coolant substance contained therein. This property allows every set of gel packs to be conveniently stored at a very low temperature in one freezer until needed. Since each gel pack is made of transparent material, a dye substance may be added to each coo substance so its freezing properties may be easily determined.
The improved method of initial applying cryotherapy that elicits less pain when initially applied by gradually lowering the skin temperature of the joint or body part. The improved method comprises the following steps: (1) selecting and attaching a properly fitting a device which can hold two attached gel packs on substantially opposite sides of the joint; (2) selecting a frozen first set of gel packs containing a coolant substance having a freezing temperature of approximately 30 degrees F.; (3) placing one gel pack from the first set of gel packs into each pocket for approximately twenty to sixty minutes; (4) removing the first set of gel packs from each pocket; (5) selecting a frozen second set of gel packs containing a coolant substance having a freezing temperature of approximately 25 degrees F.; (6) placing one gel pack from the second set of gel into each pocket for approximately twenty to sixty minutes; (7) keeping each gel pack from the second set of gel packs in each pocket until cryotherapy treatment is completed, and; (8) removing the device from the joint.
An improved method for applying extended cryotherapy treatment to a joint is also disclosed using multiple sets of gel packs which lower and raise the skin temperature of the joint or body part during treatment. The improved method comprises the following steps: (1) selecting and attaching a properly fitting device which can hold at least two attached gel packs on substantially opposite sides of a joint; (2) selecting a frozen set of first set of gel packs containing a coolant substance having a freezing temperature of approximately 30 degrees F.; (3) placing one gel pack from the first set of gel packs into each pocket on the device so that each gel pack is disposed on substantially opposite sides of the joint; (4) keeping the device attached to the joint continuously until the temperature of the skin located immediately around the joint is between 40 and 45 degrees F.; (5) exchanging the first set of gel packs with a frozen second set gel packs containing a coolant substance having a freezing temperature of approximately 25 degrees F.; (6) keeping the device attached to the joint continuously until temperature of the skin located immediately around the joint is between 30 to 40 degrees F.; (7) removing the second set of gel packs from each pocket; (8) repeating steps 3 through 7 for 3 to 24 hours or until swelling or pain is reduced, and; (9) removing the device from the joint.
For special conditions and applications, a frozen third set of gel packs containing coolant substance with a freezing temperature of approximately 18 degrees F. may be used for 15 to 30 minutes between steps (7) and (8) for further cooling.